Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04543916
Status:
WITHDRAWN
Last Update Posted:
2021-03-03
First Post:
2020-09-02
Brief Title:
Venetoclax and Irinotecan in RelapsedRefractory SCLC
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
A Phase 12 Study of Venetoclax and Irinotecan in RelapsedRefractory Small Cell Lung Cancer
Status:
WITHDRAWN
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
AbbVie decided to stop trial involving Venetoclax for safety measures needed
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single-arm open-label multicenter phase 12 trial designed to establish the recommended phase 2 dose RP2D of daily oral venetoclax when given in combination with irinotecan in patients with relapsed or refractory small cell lung cancer SCLC
Detailed Description:
Irinotecan will be given at 60 mgm2 on days 1 8 and 15 of each 28-day cycle A 33 dose escalation design will be followed until the maximum tolerated dose MTD of venetoclax has been determined Once the MTD is established a RP2D that is the same as or less than the MTD will be determined If no RP2D can be determined the study will close to accrual The RP2D will be used in an expansion cohort based on a Simons two-stage minimax design to evaluate efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HM20019851 | OTHER | Virginia Commonwealth University Massey Cancer Center | None |